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Appendix

EzRay Air Portable (Model: VEX-P300) User Manual

A.4.3

Scattered Dose

Scope

IEC 60601-2-65 203.13

Requirements

ME EQUIPMENT shall be provided with means to optionally allow actuation of the

EXPOSURE from a PROTECTED AREA after installation.
Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS.

Results

The following exposure timetables were established with a unit equipped with a cone

that corresponds to a focus-to-skin distance of 200 mm (8 inches), respectively.

Test Equipment

Instrument

Manufacturer

Model

S/N

X / Gamma

Survey Meter

Radcal Co.

9015/10X5-180

91-1470/19069

Method

PMMA Phantom aligned to 280 mm away from Focal Spot

Max. Exposure Condition

Measure point: 1000 mm from PMMA Phantom

Содержание EzRay Air Portable

Страница 1: ...User Manual Model VEX P300 Version 1 49 Full Version English Postal Code 18449 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do Korea www vatech com User manual ...

Страница 2: ......

Страница 3: ...dures and safety instructions if needed The illustrations photos of the device in this manual are only for illustration purposes The actual device may differ Due to continuous technological improvements the manual may not contain the most updated information For further information not covered in this manual please contact us at VATECH Co Ltd Phone 82 1588 9510 E mail gcs vatech co kr This documen...

Страница 4: ...Notice ii EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 5: ...tions 10 2 Safety Instructions 11 2 1 General Safety Guidelines 11 2 2 Warnings and Safety Instructions 12 3 System Overview 15 3 1 Indications for Use 15 3 2 Principles of Operation 15 3 3 Intended User Profile 15 3 4 Components 16 3 5 Features 17 3 6 General View of the Device 18 4 Operation 23 4 1 Power On Off 23 4 2 Enter Password 24 4 3 Operation Mode 25 4 4 Positioning 27 4 5 Exposure 36 4 6...

Страница 6: ...e Specifications 71 9 1 Mechanical Specifications 71 9 2 Technical Specifications 72 9 3 Electrical Specifications 76 9 4 Environmental Specifications 76 Appendix 77 A 1 How to Attach a Device to a Tripod 77 A 1 How to Use Rotating Rectangular Cover 80 A 2 Tables of Exposure Times Default 82 A 3 X ray Dose Data 86 A 4 Electromagnetic Compatibility EMC Information 95 A 5 Abbreviations 98 ...

Страница 7: ...ncial or local regulatory compliance and that VATECH its agents or representatives do not accept responsibility for 1 any injury or danger to personnel from X ray exposure 2 image over underexposure due to poor operating techniques or procedures 3 device which has been damaged modified or tampered with in any way 1 2 Owner and Operator s Obligation This device owner must perform constancy tests at...

Страница 8: ...d in this document to prevent personal injury and damage to the device Indicates a potentially hazardous situation and improper handling may result in Serious bodily injury User or veterinary patient Substantial property damage Indicates a potentially hazardous situation and improper handling may result in Light injury Property damage Indicates a potentially harmful situation and improper handling...

Страница 9: ...uments Main Label Dangerous voltage Powerboard X ray Generator Generator Label Off power disconnect from the main switch Battery bay access door outside On power connect to the main switch Battery bay access door outside IEC60601 1 Degree of Protection from Electric Shock TYPE B Equipment Main Label Radiation hazard Generator Label UL mark No E476672 Main Label Caution Federal law restricts this d...

Страница 10: ...nicipal waste and must be collected separately Main Label ESD susceptibility symbols indicate that an item is susceptible to damage from electrostatic discharges Board package Refer to the User Manual Main Label Using a Torx wrench unscrew the battery bay access door Main Label Lift the door after the removal of the screw Main Label This symbol indicates the direction of cover attachment detachmen...

Страница 11: ...on EzRay Air Portable Model VEX P300 User Manual 9 ENGLISH 1 4 1 Label Locations 1 Generator Label 2 Main Label 3 UDI Label The labels design and contents may be different in some countries based on local regulations and standards 1 2 3 ...

Страница 12: ... 1 2014 IEC 60601 1 3 2008 IEC 60601 2 65 2012 ISO 13485 21 CFR 1020 30 1020 31 This is Class IIb equipment and obtained CE marking in April 2007 for regulation compliance by the revised European Union s MDD Medical Devices Directive 93 42 EEC This equipment received the UL certification mark in accordance with ANSI AAMI CAN CSA C22 2 No 60601 1 regulation Classifications IEC60601 1 6 1 Protection...

Страница 13: ...evice is not in use Always disconnect the power supply before cleaning the device DO NOT keep the device or its parts in a humid place or a liquid substance Avoid placing the device near chemical storage and gas filled storage facilities The backscatter shield protects users from backscatter radiation that they might be exposed to during X ray exposure Operating the device with the backscatter shi...

Страница 14: ...ids may cause an electrical shock or otherwise damage the system DO NOT use spray cleaners on this device as this could cause a fire Never use this device in an environment that is susceptible to explosion DO NOT place flammable materials near this device Never touch the patient while also touching the SIP SOP connectors The medical electrical device is subject to special EMC preventive measures F...

Страница 15: ...subject batteries to mechanical shock In a cell leaking event do not allow the liquid to meet the skin or eyes If the contact has been made wash the affected area with copious amounts of water and seek medical advice Keep the battery away from children and pets DO NOT make the battery wet or let it be in the water Keep batteries clean and dry Seek medical advice immediately if a battery has been s...

Страница 16: ... sure to charge the battery frequently This helps to ensure the life of the battery Radiation Safety When using the device it is recommended that all users comply with the following radiation safety guidelines for the users and the patients safety All users and patients should wear a protective device such as a lead apron thyroid collar etc This device should be operated in an area that is more th...

Страница 17: ...chnician for both adult and pediatric patients 3 2 Principles of Operation X rays are emitted when a high voltage is supplied to the X ray tube assembly which frees electrons from the cathode They hit anode to produce X rays The device acquires images by emitting X rays continuously on the human tooth 3 3 Intended User Profile Considerations Requirement Description Education A licensed dentist or ...

Страница 18: ...eld and the Round Cover 1 2 Hand Neck Strap 1 3 Rectangular Cover 4x3 1 4 power cord 1 5 Battery Charger 1 6 User Manual 1 7 Cradle 1 8 Rectangular Cover 2x3 1 9 Rotating Rectangular Cover 4x3 1 10 Rotating Rectangular Cover 2x3 1 11 Remote Exposure Switch 1 12 Base Holder 1 13 Tripod 1 Read the notice on the next page for the options with the symbol ...

Страница 19: ...act a VATECH representative in your area 3 5 Features The device is an intra oral portable X ray system that offers safety reliability and greater functionality Lightweight and ergonomic design The convenience of cordless design by using battery pack Micro computer and a specialized circuit that monitors and precisely regulates the exposure technique factors kV mA and exposure time Pre programmed ...

Страница 20: ...on for X ray exposure 4 Handle Grip the handle securely when using the system 5 Power Button Power On Off button 6 Battery Rechargeable Lithium ion battery 7 Adaptor Connector Connect the charging adaptor 8 Remote X ray Exposure Switch Port Connect the X ray exposure cable switch Alternatively it can be used as a service port 9 Strap Loop Connect the strap 10 Control panel Display for the X ray ex...

Страница 21: ...ooling time and exposure angle 3 Adult Child Selection Indicates a patient type adult or child 4 Remaining Battery Indicator Indicates remaining battery level Battery Charging Indicator 1 Indicates that the battery charger is connected to the device 2 Indicates the battery needs to be charged when it flickers 5 SET Button Resets the X ray exposure angle 6 Speaker Sound alarm for the X ray exposure...

Страница 22: ...l left or right to select an X ray exposure setting press the jog dial to confirm the operating setting 10 AUTO Button Available only in countries that allow the auto mode for use The mode is not available in the United Kingdom the United States and some countries Consult the sales representative in your country for details In these countries only NA is displayed on the panel when this button is p...

Страница 23: ...4x3 and 3x4 4 Rotating Rectangular Cover 2x3 3x2 FOV 2x3cm 3x2cm This adaptor can be used as both 2x3 and 3x2 5 Base Holder 6 Cradle 7 Tripod In case a tripod is used with the Base Holder refer to the specifications below Fixing bolt size 3 8 inch Maximum supportable weight about 5 kg Minimum height 130 cm More than 3 columns are required When using a tripod with 3 columns make sure to have space ...

Страница 24: ...3 System Overview 22 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 25: ...ight up Current Angle Time display Tooth type selection display Adult Child selection display Remaining battery indicator X ray exposure indicator 3 Make sure that at least one battery indicator light comes on Battery level 1 When the battery indicator has one flickering light charge the battery immediately by using the battery charger For more information refer to 4 6 Using the Battery ON OFF ...

Страница 26: ...to 5 3 4 Password mode On Off To change the password refer to 5 3 11 Password Setting 1 Enter the 3 digits numeric password using the jog dial default password 000 2 Turn the jog dial to choose a number and press the dial to move to the next digit 3 When all three digits are set press the jog dial again to save the setting ...

Страница 27: ...ed in Manual Mode Manual Mode 1 When the tooth type selection area flickers turn the jog dial to select the tooth type To see the Control panel before and after selection refer to the figures below Before tooth type selection After tooth type selection Tooth Type Symbol Type Incisor Canine Molar Premolar Bitewing ...

Страница 28: ...t type selection Patient Type Symbol Type Adult Child After the tooth type and patient type are selected the exposure time is automatically displayed 3 When changing the exposure time turn the jog dial to adjust the exposure time from 0 05 to 1 0 s increments 0 01 s When pressing the jog dial after adjusting the exposure time in Manual Mode the exposure time is returned to the default setting To s...

Страница 29: ... process positioning the patient and the X ray imaging system exposing the phosphor plate or the intra oral sensor 1 Place a protective lead apron on the patient s chest 2 Have the patient sit on the chair with the sagittal plane vertical For radiography of the upper maxillary the Frankfort plane must be horizontal For radiography of the lower maxillary the Occlusal plane must be horizontal Frankf...

Страница 30: ... To learn the proper use of each of these components see 4 5 1 Remote Exposure Switch and A 1 How to Attach a Device to a Tripod DO NOT touch the cone when the exposure begins During the exposure the backscatter shield must stay parallel to the operator to keep the person in a protected zone Depending on the imaging angles exposure times vary Since it is necessary to keep the patient with low X ra...

Страница 31: ...d angle technique The patient holds the phosphor plate or sensor in place with his her finger The X ray beam is directed perpendicularly towards an imaginary line which bisects the angle between the phosphor plate or sensor plane and the tooth s long axis Position the tube head to the patient using the accepted standard positioning procedures 1 Phosphor plate or Sensor 2 Long axis of the tooth 1 P...

Страница 32: ...ges of a tooth i e Bisected angle technique Position the receptor carefully not to damage the soft tissue of the patient s intra oral area Maxillary Incisor The x ray beam is directed downward at 45 Teeth Angle of inclination Incisor Maxilla 45 Mandibular Incisor The x ray beam is directed upward at 25 Teeth Angle of inclination Incisor Mandible 25 ...

Страница 33: ...VEX P300 User Manual 31 ENGLISH Maxillary Canine The x ray beam is directed downward at 45 Teeth Angle of inclination Canine Maxilla 45 Mandibular Canine The x ray beam is directed upward at 20 Teeth Angle of inclination Canine Mandible 20 ...

Страница 34: ...nual Maxillary Molar and Premolar The x ray beam is directed downward at 30 Teeth Angle of inclination Molar and Premolar Maxilla 30 Mandibular Molar and Premolar The x ray beam is directed upward at 5 Teeth Angle of inclination Molar and Premolar Mandible 5 ...

Страница 35: ...VEX P300 User Manual 33 ENGLISH Bitewing For a bitewing exposure the patient closes their teeth during exposure on the phosphor plate sensor holder The x ray beam is directed downward at 5 8 Teeth Angle of inclination Bitewing exposure 5 8 ...

Страница 36: ...raph such as distorted teeth and roots elongation magnification and overlapping contacts The paralleling technique generally reduces the risk of such errors but if the sensor s position improperly angulation errors may occur angulation of the sensor to the tooth itself Failure to align the imaging sensor with the X ray beam s exit pattern can result in cone cuts on the radiograph The cone cuts are...

Страница 37: ... and the X ray beam it is recommended to use a PID Position Indicating Device as shown in the following figure When using the PID the X ray device s exit pattern should be aligned perpendicular to the target receptor as shown in the following figure Once the PID is appropriately aligned instruct the patient not to move PID ...

Страница 38: ...d X ray device is prohibited must use a remote exposure switch See 4 5 1 Remote Exposure Switch for details 3 While X ray is being exposed The X ray Exposure Indicator lights up and an audible sound is produced Keep pressing until the X ray Exposure Indicator light goes off and the audible sound stops Green Ready Yellow X ray On Hold the Exposure Button or switch if the acoustic signal can be hear...

Страница 39: ... of the Remote Exposure Switch will abort image acquisition Pressing the Remote Exposure Switch activates the X ray Exposure Indicator to turn yellow This color indicates that the X ray is being emitted The Remote Exposure Switch is detachable Ensure that the Remote Exposure Switch cable is not detached out from the unit accidentally during the operation Keep vocal visual contact with the patient ...

Страница 40: ...e battery immediately The figure below shows each battery indicator from level 1 to 3 Level 3 Level 2 Level 1 When the battery reaches Level 1 charge the battery at least for an hour to avoid a low voltage All displays are turned off under the low voltage except for the error code A 10 as shown see the figure below After the device is connected to the battery charger and the battery level becomes ...

Страница 41: ... Not operated Battery Level Indicator Normal Normal Flickers Not displayed Battery Charging Indicator Not displayed Not displayed Flickers Not displayed Control panel Brightness Normal Normal Normal Normal Error code A 10 is only displayed Make sure to charge the battery if the Battery Charging Indicator flickers or the error code A 10 is displayed If the device has been turned on for long periods...

Страница 42: ... charge the battery after a complete discharge fully 3 When the battery charge is completed remove the battery charger from the device It is not able to perform an exposure while the battery charger is connected to the device Battery Use Cycle The battery is a consumable part It is expected to degrade gradually so it should be recharged more frequently When the battery duration decreases to half o...

Страница 43: ...e battery contact your Service Representative to get a battery kit including a new battery and a Phillips screwdriver 1 Workforce One person 3 minutes 2 Tools required Phillips screwdriver size T20 3 Removal Procedure 1 Using a Phillips screwdriver unscrew the battery bay access door 2 Lift the door and remove the battery Battery ...

Страница 44: ...y cable by pressing the battery cable connector as shown in the following figure DO NOT pull excessively on the battery cable 4 Install the new battery in the reverse order of removal Press and disconnect the battery cable connector Battery cable connector After disconnecting the battery cable ...

Страница 45: ...e default waiting time for Sleep Mode 1 see 5 3 6 Waiting Time Setting for the Sleep Mode 1 1 When Sleep Mode 1 starts the Control panel becomes lightly dark as shown in the right figure Brightness Normal Brightness Lightly dark 2 To return to normal operation press any button on the device except for the X ray Exposure Button When the device is not in use turn off the power to avoid battery consu...

Страница 46: ...ing Time Setting for the Sleep Mode 2 If the battery charger is connected to the device Sleep Mode 1 is maintained When Sleep Mode 2 starts all displays are turned off on the Control panel as shown in the right figure Brightness Lightly dark Brightness Dark 1 To return to normal operation press any button on the device except for the X ray Exposure Button When the device is not in use turn off the...

Страница 47: ...e the default waiting time for the Power Down Mode see 5 3 8 Waiting Time Setting for the Power Down Mode If the battery charger is connected to the device Sleep Mode 1 is maintained 1 All displays are turned off on the Control panel 2 To return to normal operation in the Power Down Mode MUST turn off the system and turn it back on Refer to 5 3 10 Power Down Mode On Off to disable the mode ...

Страница 48: ...4 Operation 46 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 49: ...s 5 3 2 Exposure Time Settings for each patient and tooth type 5 3 3 User Default Settings for each patient and tooth type 5 3 4 Password Mode On Off 5 3 5 Angle Increments Setting 5 3 6 Waiting Time Setting for the Sleep Mode 1 5 3 7 Waiting Time Setting for the Sleep Mode 2 5 3 8 Waiting Time Setting for the Power Down Mode 5 3 9 Buzzer On Off 5 3 10 Power Down Mode On Off 5 3 11 Password Settin...

Страница 50: ... System Parameters To change system parameters 1 Press and hold the SET button and jog dial simultaneously for about 3 seconds 2 Enter the 3 digits numeric password using the jog dial default password 000 2 Turn the dial to choose a number and press it to move to the next digit ...

Страница 51: ...jog dial again to save the setting 4 After entering the password is completed the service mode starts as shown in the figure below 5 The system provides 24 service modes To change each mode s settings from n 01 to n 24 press the AUTO button on the left Upon pressing the button n 01 is displayed on the control panel ...

Страница 52: ...to the previous move press the SET button on the right See 5 3 Service Mode Menu to learn more information on each mode 7 Each time you finish changing the system parameter press the jog dial and hold it until you hear a beep 8 To resume the operation press the SET button and the jog dial simultaneously and hold them for about 3 seconds 9 Restart the device to check if the change is saved correctl...

Страница 53: ...ult values except for n 24 Follow the procedures below to activate the settings Service Mode No Item n 01 Factory default settings To restore the system to the factory default settings 1 Select n 01 and press the jog dial When the message YES is displayed on the control panel the system is restored to its initial settings 2 To save the setting press the jog dial and hold it until you hear a beep 3...

Страница 54: ...dult Canine n 04 Adult Molar Premolar n 05 Adult Bitewing n 06 Child Incisor n 07 Child Canine n 08 Child Molar Premolar n 09 Child Bitewing To set the exposure time for a specific patient and tooth type as described above 1 Select the Service Mode number according to the patient and tooth type i e n 06 for Child Incisor 2 After entering the mode turn the jog dial to adjust the exposure time 3 Pre...

Страница 55: ... Incisor n 13 Canine n 14 Molar Premolar n 15 Bitewing To set the default setting for a specific patient type or a tooth type 1 Select a service mode number between n 10 Adult and n 11 Child for a specific patient type and from n 12 to n 15 for a tooth type For instance when select n 10 by pressing the jog dial to set the patient type adult as default then YES is displayed on the Control panel 2 P...

Страница 56: ...ord Off To activate the password mode 1 Select n 16 and press the jog dial The message YES is displayed on the Control panel 2 Press the dial again and hold it until you hear a beep 3 Restart the device to check if the setting is saved correctly 4 To deactivate the password mode select n 17 and repeat the procedure In the United States Password Mode is set as a default and cannot be turned off by ...

Страница 57: ... the angle increments for the Auto Mode Service Mode No Item n 18 Angle increments setting When using the Auto Mode the angle value increases and decreases according to the increments setting default 1 degree The angle increments can be set from 1 to 5 degrees To change the angle increments setting 1 Select n 18 and press the jog dial The default angle increments 001 is displayed on the control pa...

Страница 58: ...ime setting for the Sleep Mode 1 To change the waiting time for Sleep Mode 1 1 Select n 19 and press the jog dial The default time 001 1 minute is displayed on the control panel as shown in the right figure 2 Turn the jog dial to the right to change the time The selection is available from 1 to 999 minutes 3 Press the dial again until you hear a beep 4 Restart the device to check if the new settin...

Страница 59: ... time setting for the Sleep Mode 2 To change the waiting time for Sleep Mode 2 1 Select n 20 and press the jog dial The default time 005 5 minutes is displayed on the control panel as shown in the right figure 2 Turn the dial to change the default time The selection is available from 1 to 999 minutes 3 Press the dial again and hold it until you hear a beep 4 Restart the device to check if the new ...

Страница 60: ...etting for the Power Down Mode To change the waiting time for the Power Down Mode 1 Select n 21 and press the jog dial The default time 300 300 minutes is displayed on the control panel as shown in the right figure 2 Turn the jog dial to change the default time The selection is available from 5 to 999 minutes 3 Press the dial again and hold it until you hear a beep 4 Restart the device to check if...

Страница 61: ...elect n 22 and press the jog dial The default setting 002 Buzzer On for Power Down Mode only is displayed on the control panel as shown in the right figure 2 Turn the jog dial to select an option out of the four options as described below 3 Press the dial again and hold it until a beep is heard 4 Restart the device to check if the new setting is saved correctly optional 000 Buzzer Off 001 Buzzer O...

Страница 62: ...Down Mode On Off setting 1 Select n 23 and press the job dial The default setting 001 is displayed on the Control panel 001 On 000 Off 2 To turn off the Power Down Mode turn the dial to change the setting from 001 to 000 3 Press the dial again and hold it until a beep is heard 4 Restart the device to check if the new setting is saved correctly 5 To turn on the Power Down Mode again select n 23 and...

Страница 63: ...ge the password 1 Select n 24 and press the jog dial The default password 000 is displayed on the control panel as shown in the right figure 2 When the first digit flashes turn the jog dial to change the password and then save it by pressing the jog dial 3 Follow the same procedure for the next two digits 4 Press the dial until you hear a beep 5 Check if the new password has been correctly saved ...

Страница 64: ...5 Service Mode 62 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 65: ... normal operations after a re boot If the problem persists please contact your VATECH representative E 03 E 04 E 05 A 06 Appears when the system needs cooling time due to continuous operation This alarm clears when the system temperature goes down to normal A 07 System Appears when the power is turned on while the user is pressing the Exposure Button or Remote Exposure Switch Release the switch A ...

Страница 66: ...nnected Contact your Service Representative No X ray emission The generator is cooling Wait for the cooling time refer to Duty Cycle Defective Remote Exposure Switch Contact your Service Representative Internal cable disconnected Contact your Service Representative Defective generator Contact your Service Representative Tube lifecycle termination Contact your Service Representative X ray emission ...

Страница 67: ...cessary wipe off surfaces with disinfectant If necessary wipe off surfaces with disinfectant Please observe the hygiene instructions of the phosphor plate scanner manufacturer When cleaning the surfaces make sure that the device is not connected to the battery charger DO NOT expose the device to any liquids DO NOT use spray cleaner or disinfectant directly into the device as this could cause a fir...

Страница 68: ...device For technical assistance contact the VATECH service center or your local VATECH representative Please observe the maintenance instructions of the phosphor plate scanner manufacturer Cautions and Notes DO NOT keep the device or its parts in a humid place or near a liquid substance Avoid placing the device near chemical storage and gas filled storage facilities When the device is not in use f...

Страница 69: ...ean the outer covers of the device Daily Ensure that the signal is audible and the X ray emission light is visible when making an exposure Daily Ensure that the yellow exposure indicator light turns on when the Exposure Button is pressed Daily Ensure that the battery charging LED indicator comes on when charging the battery Daily Ensure that the battery level indicator displays at least two levels...

Страница 70: ...7 Cleaning and Maintenance 68 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 71: ...cs Boards Cables and transformer Copper Packing Polystyrene Cardboard Paper X ray tube Battery Other parts Observe all regulations relevant to the disposal of waste in your country This symbol on the device and accompanying documents means that used electrical and electronic devices WEEE should not be mixed with general household waste For professional users in the European Union When discarding e...

Страница 72: ...8 Disposing of the Unit 70 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 73: ...9 Device Specifications 9 1 Mechanical Specifications Dimensions Item Description Main Body Dimension mm 280 L x 296 H x ø 165 Weight kg 2 14 10 X ray Beam Limiting Device X ray Beam Area mm Round Type FOV ø 60 Rectangular Type FOV 20 x 30 40 x 30 SSD Source to Skin Distance mm 200 ...

Страница 74: ...n Thermistor 65 C Inherent Filtration 1 8 mm Al 65 kV Total Filtration Min 1 5 mm Al Type Inverter Type Tube Voltage 55 65 kV Tube Current 1 0 3 0 mA X ray Tube Manufacturer VATECH Co Ltd Model V1 650304 Stationary Anode type Focal spot size 0 4 mm IEC 60336 Anode heat contents Max 2 7 kJ Maximum Anode Heat Dissipation 200 W Target Material Tungsten Target Angle 12 5 Inherent Filtration Min 1 5 mm...

Страница 75: ... Specifications EzRay Air Portable Model VEX P300 User Manual 73 ENGLISH X ray Tube Characteristics 1 Maximum rating chart 2 Emission characteristics 3 Heating and cooling curves of X ray tube housing assembly ...

Страница 76: ...9 Device Specifications 74 EzRay Air Portable Model VEX P300 User Manual 4 Tube Dimensions mm ...

Страница 77: ...sing an unauthorized battery may result in severe injury and device damage For details on using the battery see Battery Use Battery Charger Item Description Model XVE 2520200 Manufacturer JIN XIN YU POWER SHENZHEN SUPPLY CO LTD Rating Input 100 240 V 50 60 Hz 1 5A Output 25 2 Vdc 2 0 A Frequency 50 60 Hz Standard IEC 60950 1 UL Power Cord 300 V 2 5 A Make sure to use the battery charger only provi...

Страница 78: ...e 21 6 Vdc The system will be available with a fixed tube voltage specification based on the user selection 9 4 Environmental Specifications Item Description During operating Temperature 10 35 Relative humidity 30 75 Atmospheric pressure 860 1060 hPa Transport and storage Temperature 10 60 Relative humidity 10 75 non condensing Atmospheric pressure 860 1060 hPa Failure to follow the specifications...

Страница 79: ...osure Switch using a Base Holder provided by VATECH Base holder Remote Exposure Switch Cables and tripod are provided as options and shipped in a separate package See Available Option Items in Chapter 3 Demount the device from the tripod by following each step in reverse order WorkForce 1 or 2 person s Required tool A screwdriver with a magnetic tip preferred Mounting Procedure 1 Prepare the Base ...

Страница 80: ...e Base Holder s bottom part to the Tripod s baseplate 4 Put the device on the holder s bottom part and place the upper part over the device See below Insert each cross head screw into a hole and tighten it with a screwdriver Ensure that the Base holder s bottom part is securely attached to the Tripod s base plate before connecting the upper part Ensure to hold the device to avoid a fall while conn...

Страница 81: ...ttached to the Base Holder on the Tripod 6 How to connect the Remote X ray Exposure Switch Connect the Gender Cable to the Base Holder using the screwdriver And plug the Cable s end into the Remote X ray Exposure Switch Port 7 Connect the Remote X ray Exposure Switch to the Gender Cable ...

Страница 82: ... A 2 How to Use Rotating Rectangular Cover Rotating Rectangular Cover rotates at 360 degrees Rotating Rectangular Cover consists of the Outer Ring and the Inner Ring The Outer Ring rotates in 90 degree increments The Inner Ring rotates in 10 degree increments ...

Страница 83: ...ular Cover to the Cone turn the Rotating Rectangular Cover 45 degrees and check the Click sound to ensure the assembly is complete 2 Turn the Outer Ring of the Rotating Rectangular Cover to adjust the angle roughly 3 Turn the Inner Ring of the Rotating Rectangular Cover to fine tune the angle When disassembling the rotating cover follow the assembly steps in reverse order ...

Страница 84: ...tively DIGITAL SENSOR 1 Option 1 60 kV 2 5 mA 0 05 1 0 sec Patient Teeth Angle of inclination SSD 200 mm 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 60 2 5 0 14 Canine Maxilla 45 Mandible 20 60 2 5 0 16 Molar Premolar Maxilla 30 Mandible 5 60 2 5 0 18 Bitewing 5 8 60 2 5 0 20 Child Incisor Maxilla 45 Mandible 25 60 2 5 0 12 Canine Maxilla 45 Mandible 20 60 2 5 0 14 Molar Premolar Maxilla...

Страница 85: ...m 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 65 2 5 0 12 Canine Maxilla 45 Mandible 20 65 2 5 0 14 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 16 Bitewing 5 8 65 2 5 0 18 Child Incisor Maxilla 45 Mandible 25 65 2 5 0 10 Canine Maxilla 45 Mandible 20 65 2 5 0 12 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 14 Bitewing 5 8 65 2 5 0 16 ...

Страница 86: ...on SSD 200 mm 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 60 2 5 0 30 Canine Maxilla 45 Mandible 20 60 2 5 0 42 Molar Premolar Maxilla 30 Mandible 5 60 2 5 0 60 Bitewing 5 8 60 2 5 0 65 Child Incisor Maxilla 45 Mandible 25 60 2 5 0 20 Canine Maxilla 45 Mandible 20 60 2 5 0 25 Molar Premolar Maxilla 30 Mandible 5 60 2 5 0 40 Bitewing 5 8 60 2 5 0 40 ...

Страница 87: ...m 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 65 2 5 0 28 Canine Maxilla 45 Mandible 20 65 2 5 0 40 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 58 Bitewing 5 8 65 2 5 0 63 Child Incisor Maxilla 45 Mandible 25 65 2 5 0 18 Canine Maxilla 45 Mandible 20 65 2 5 0 23 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 38 Bitewing 5 8 65 2 5 0 38 ...

Страница 88: ...el Name DG S0101V1 Inverter type Loading Factor Option 1 60 kV 2 5 mA Option 2 65 kV 2 5 mA A 4 1 X ray Dose Table Test Equipment Instrument Manufacturer Model S N Multi Dose Meter Raysafe Unfors Xi mAs Unfors Xi R F MAM 163288 161834 Digital Sensor Dose Area Product DAP Table 60 kVp 2 5 mA SSD 200 mm FOV Ø 6 cm FOV 3 x 4 cm FOV 2 x 3 cm t s Dose mGy cm2 0 14 6 5 2 8 1 4 0 16 7 5 3 2 1 6 0 18 8 5 ...

Страница 89: ...age Dose Scope IEC 60601 2 65 203 12 4 Requirements In the LOADING STATE the AIR KERMA due to LEAKAGE RADIATION from X RAY SOURCE ASSEMBLIES 1 m from the FOCAL SPOT average over an area of 100 cm2 of which no principal linear dimension exceeds 20 cm when operated at the NOMINAL X RAY TUBE VOLTAGE under the condition of LOADING corresponding to the reference LOADING conditions shall not exceed 0 25...

Страница 90: ... 2x3 and rectangular 4x3 all the results have been ND Not Detected The raw data about the results are shown in the table below The result Horizontal Plane Direction Default type Rectangular 2x3 Rectangular 4x3 mGy h mGy h mGy h 0 ND ND ND 20 ND ND ND 45 ND ND ND 65 ND ND ND 90 ND ND ND 110 ND ND ND 135 ND ND ND 155 ND ND ND 180 ND ND ND 200 ND ND ND 225 ND ND ND 245 ND ND ND 270 ND ND ND 290 ND ND...

Страница 91: ...y h mGy h 0 ND ND ND 20 ND ND ND 45 ND ND ND 65 ND ND ND 90 ND ND ND 110 ND ND ND 135 ND ND ND 155 ND ND ND 180 ND ND ND 200 ND ND ND 225 ND ND ND 245 ND ND ND 270 ND ND ND 290 ND ND ND 315 ND ND ND 335 ND ND ND ND Not Detected The detection limit is 0 00001 mGy per exposure 0 0 2 0 4 0 6 0 8 1 1 2 0 20 45 65 90 110 135 155 180 200 225 245 270 290 315 335 ...

Страница 92: ...t instructions shall be given in the ACCOMPANYING DOCUMENTS Results The following exposure timetables were established with a unit equipped with a cone that corresponds to a focus to skin distance of 200 mm 8 inches respectively Test Equipment Instrument Manufacturer Model S N X Gamma Survey Meter Radcal Co 9015 10X5 180 91 1470 19069 Method PMMA Phantom aligned to 280 mm away from Focal Spot Max ...

Страница 93: ...irection Result Horizontal Plane μR Without Shield With Shield 0 63 4 68 14 20 17 8 11 99 45 18 5 13 01 65 19 8 14 76 90 27 1 20 65 110 41 6 32 08 135 63 4 46 18 155 68 1 11 14 180 3 29 2 893 200 51 5 7 557 225 47 5 48 63 245 33 7 33 27 270 23 4 33 25 290 19 8 18 06 315 17 2 15 23 335 19 2 14 71 ...

Страница 94: ...n Result Vertical Plane μR Without Shield With Shield 0 25 8 29 8 20 27 3 26 8 45 18 5 22 5 65 15 9 18 5 90 74 1 72 1 110 15 9 18 5 135 17 2 13 5 155 19 9 17 9 180 19 2 17 9 200 27 8 31 4 225 13 9 10 6 245 38 4 8 6 270 7 9 4 3 290 48 4 11 9 315 60 2 52 3 335 41 7 45 7 ...

Страница 95: ... 1 0 s Direction Result Horizontal Plane μR Without Shield With Shield 0 58 8 85 2 20 22 5 30 4 45 39 6 42 7 65 47 6 40 3 90 46 9 42 9 110 47 6 66 7 135 92 5 48 9 155 87 9 34 3 180 11 9 11 9 200 94 5 28 4 225 89 2 80 3 245 86 2 49 5 270 51 6 42 3 290 47 6 43 6 315 27 1 30 7 335 40 4 23 1 ...

Страница 96: ... Result Vertical Plane μR Without Shield With Shield 0 64 7 55 4 20 42 8 44 3 45 26 3 34 8 65 36 8 36 4 90 57 9 82 4 110 42 3 38 2 135 20 7 25 9 155 27 7 31 9 180 36 2 52 6 200 94 6 63 2 225 64 2 49 8 245 42 9 18 4 270 11 2 11 3 290 24 6 7 2 315 52 8 26 5 335 79 1 72 2 ...

Страница 97: ...the VEX P300 make it suitable for use in industrial areas and hospitals CISPR 11 class A If used in a residential environment for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radiofrequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment Harmonic emissions IEC 61000 3 2 Appl...

Страница 98: ... 7 GHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz The VEX P300 is suitable to use in a professional healthcare environment Immunity to Proximity Fields from RF wireless Communicati ons Equipment according to Table 9 in IEC 60601 1 2 28 V m Max 385 5785 MHz in according to table 9 28 V m Max 385 5785 MHz in according to table 9 RF communication equipment is used on closer than 30 cm to any ...

Страница 99: ...y frequency 50 60 Hz according to IEC 61000 4 8 30 A m 30 A m The magnetic field of power frequency should coincide with the general level found in the business site or hospital environment Voltage dips and short interruptions IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 Cycles Single phase at 0º 0 UT 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 ...

Страница 100: ...D Electrostatic Discharge FOV Field of View IEC International Electrotechnical Commission ISO International Standards Organization LED Light Emitting Diode ME Medical Electrical PMMA Poly Methyl Meth Acrylate RF Radio Frequency SID Source to Image receptor Distance SIP Signal Input Part SOP Signal Output Part SSD Source to Skin Distance ...

Страница 101: ...Appendix EzRay Air Portable Model VEX P300 User Manual 99 ENGLISH This page is intentionally left blank ...

Страница 102: ...Appendix 100 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank ...

Страница 103: ...tative Manufactured by VATECH Co Ltd Tel 82 1588 9510 Email gcs vatech co kr Website www vatech com Head Quarters Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Korea Factory Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Korea The CE symbol grants this device compliance to the European Directive for Medical Devices 93 42 EEC as amended by 2007 47 EC as a class IIb device...

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